Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Accuray Inc.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 059 10 11 000
  • Fecha de inicio del evento
    2011-10-22
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=938
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Accuray performed a retrofit of the synchrony camera array mounting assembly as a result of a previous report that the extension coupling worked loose and the mounting assembly unexpectedly descended. the mounting assembly weighs approximately 17 lb; unexpected contact with users or patients could result in serious injury. following the retrofit, it was found that the set screws responsible for securing the extension coupling were not tightened correctly at one site.

Device

Syunchrony, Camera array mounting assembly
  • Modelo / Serial
    C185
  • Descripción del producto
    Radiosurgery, Camera
  • Manufacturer
    Accuray Inc

Manufacturer

Accuray Inc
  • Empresa matriz del fabricante (2017)
    Accuray Inc
  • Representante del fabricante
    Gulf Medical Co.
  • Source
    SFDA